FDA

FDA Warns Against Unapproved Erectile Dysfunction Products

FDA Warns Against Unapproved Erectile Dysfunction Products

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Unapproved erectile dysfunction drugs are touted as a "healthy man alternative to the little blue pill."

NCCN Recs Go Beyond FDA-Approved Indications

NCCN Recs Go Beyond FDA-Approved Indications

NCCN recommended 47 FDA-approved drugs for 113 indications; 39% were extra recommendations

FDA Approves New Treatment for Drug-Resistant HIV

FDA Approves New Treatment for Drug-Resistant HIV

Trogarzo is given intravenously once every 14 days in combination with other antiretrovirals

FDA Purging Kratom Products

FDA Purging Kratom Products

Missouri-based Divinity Products Distribution will recall and destroy kratom-containing products

Clarithromycin May Damage Heart, FDA Warns

Clarithromycin May Damage Heart, FDA Warns

Agency advising doctors to consider prescribing other antibiotics to patients with coronary heart disease

Botanical Kratom Contains Opioids, FDA Warns

Botanical Kratom Contains Opioids, FDA Warns

Calls to poison centers regarding kratom increased 10-fold between 2010 and 2015

FDA Approves Short Acting Insulin Drug for Diabetes

FDA Approves Short Acting Insulin Drug for Diabetes

The FDA just approved a new short-acting insulin drug, Admelog, for patients with either T1D or T2D.

FDA Approves Semiglutide for Type 2 Diabetes

FDA Approves Semiglutide for Type 2 Diabetes

Semaglutide helps patients with diabetes reduce blood glucose levels and lower body weight.

Drug Approved for Complicated Urinary Tract Infections

Drug Approved for Complicated Urinary Tract Infections

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Vabomere, which combines meropenem and vaborbactam, demonstrated superior efficacy to piperacillin/tazobactam.

FDA May Lower Nicotine Levels in Cigarettes to Non-Addictive Levels

FDA May Lower Nicotine Levels in Cigarettes to Non-Addictive Levels

The FDA is delaying implementation of last year's rules on cigars and electronic cigarettes currently on the market until 2021 and 2022, respectively.

FDA Will Increase Generic Drugs

FDA Will Increase Generic Drugs

The agency will now give priority reviews to new generic drugs until there are 3 on the market.

FDA: Canagliflozin May Increase Risk of Foot, Leg Amputations

FDA: Canagliflozin May Increase Risk of Foot, Leg Amputations

Amputations of the toe and middle of the foot were the most common, but leg amputations below and above the knee also occurred.

Anemia Indication Sought for Phosphate Binder

Anemia Indication Sought for Phosphate Binder

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Company asks FDA to approve ferric citrate for iron deficiency anemia in patients with non-dialysis dependent chronic kidney disease.

First Drug Approved to Treat Nocturnal Polyuria

First Drug Approved to Treat Nocturnal Polyuria

Noctiva is taken 30 minutes before bed and is designed to increase absorption of water through the kidneys.

Nivolumab Approved for Refractory Urothelial Carcinoma

Nivolumab Approved for Refractory Urothelial Carcinoma

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The drug is indicated for treating patients with locally advanced or metastatic disease that progresses despite platinum-containing chemotherapy.

Bladder Cancer-Pioglitazone Link Reasserted by FDA

Bladder Cancer-Pioglitazone Link Reasserted by FDA

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After analyzing new data, the FDA again warns that the diabetes drug may be associated with an increased risk for bladder cancer.

FDA Approves Removal of Boxed Warning for Hyperkalemia Drug

FDA Approves Removal of Boxed Warning for Hyperkalemia Drug

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Updated label for patiromer now recommends the drug be taken at least 3 hours before or after other oral medications.

FDA Adds Abuse Warning to All Testosterone Products

FDA Adds Abuse Warning to All Testosterone Products

The new FDA warning alerts prescribers to the abuse potential of testosterone.

FDA Adds New Testosterone Warnings

FDA Adds New Testosterone Warnings

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Labeling changes will alert prescribers to the abuse potential of testosterone and the serious adverse effects.

FDA Approves Enzalutamide Labeling Update

FDA Approves Enzalutamide Labeling Update

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Labeling information will include data showing the drug reduces the risk of radiographic progression versus bicalutamide.

FDA Approving More Abuse-Deterrent Opioids

FDA Approving More Abuse-Deterrent Opioids

While ADFs of opioids may help mitigate the risk of opioid abuse, they have limitations as well.

FDA Approves Adlyxin to Treat Type 2 Diabetes

FDA Approves Adlyxin to Treat Type 2 Diabetes

Once-daily injection to improve glycemic control, along with diet and exercise.

FDA Adds Safety Warnings to Fluoroquinolones

FDA Adds Safety Warnings to Fluoroquinolones

Fluoroquinolones such as Cipro, Levaquin should be reserved for life-threatening infections.

FDA Approves First Absorbable Stent for CAD

FDA Approves First Absorbable Stent for CAD

The Absorb GT1 Bioresorbable Vascular Scaffold System (BVS) is absorbed by the body after about 3 years.

New Drug Cleared to Treat SHPT in Chronic Kidney Disease Patients

New Drug Cleared to Treat SHPT in Chronic Kidney Disease Patients

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Calcifediol formulation is indicated for CKD stage 3 or 4 patients with secondary hyperparathyroidism associated with vitamin D insufficiency.

FDA Strengthens AKI Warning for Some SGLT2 Inhibitors

FDA Strengthens AKI Warning for Some SGLT2 Inhibitors

The Food and Drug Administration (FDA) announced it is strengthening the current warning about the risk of acute kidney injury for drug products containing canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).

Food Industry Needs to Reduce Sodium, FDA Says

Food Industry Needs to Reduce Sodium, FDA Says

The FDA has developed 2- and 10-year goals to reduce sodium content in both processed and prepared foods.

Nutrition Facts Label Revised

Nutrition Facts Label Revised

Added sugars, relevant portion sizes among the highlights of revision.

Drug Cleared for Refractory Advanced Bladder Cancer

Drug Cleared for Refractory Advanced Bladder Cancer

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Atezolizumab received accelerated FDA approval for patients whose disease has progressed despite platinum-based chemotherapy.

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